Film adhesion barrier Datsing BioPaper®

sinus surgerytendon repair surgery

Product overview

Datsing BioPaper® is a biodegradable, paper-like hemostatic membrane composed of polysaccharides, intended as an adjunct in surgical procedures to stop blood oozing, prevent tissue adhesion and seal surgical wounds.

Key features

• Stops blood oozing—acts at physical, molecular and physiological levels to control oozing in surgical wounds.
• Anti-adhesion—forms a gel layer as a physical barrier adhering to the wound surface to prevent tissue adhesion and leakage of air/substances.
• Adhesive sealing—the transparent gel layer seals the wound effectively.
• Fully biodegradable—stated to degrade into CO2 and H2O within 28 days (manufacturer statement); animal data show complete degradation within 12 weeks.

Safety

• Excellent biocompatibility; no cytotoxic effects reported.
• No skin sensitization, no irritation and no acute systemic toxicity observed.
• No risk for animal disease transmission or immunogenicity reported.
• Neutral pH.

Application
Datsing BioPaper® is suitable for use in neurosurgery, orthopedics, general surgery, cardiac and thoracic surgery, hepatobiliary surgery and urology to prevent blood oozing and tissue adhesion. In neurosurgery it may be used to seal dura mater to help prevent cerebrospinal fluid leakage.

Safety and performance information

• Intended user: for use only by physicians with appropriate training.
• Contraindications: 1) Do not use in patients with known allergy to product ingredients. 2) Patients allergic to shellfish should not use the product. 3) Not indicated for control of hemorrhage from large arteries. 4) Not for control of postpartum bleeding or menorrhagia.
• Limitations of use: maximum recommended area per patient is 360 cm2 (≈ nine pieces of 5 cm × 8 cm BioPaper).
• Product lifetime/degradation: animal studies indicate complete degradation within 12 weeks after application; manufacturer statement indicates degradation into CO2 and H2O within 28 days.
• Warnings: supplied sterile and for single use only; do not resterilize or reuse; use before expiration date; never leave plastic backing or packaging materials inside the patient; not a substitute for correct surgical technique, sutures or ligatures; keep dry prior to application; clear surgical field of excess fluid before placement.
• Precautions: can be cut, folded or curled to fit wounds; if repositioning is required, move within 20 seconds before the material becomes very sticky; foreign body reactions may occur; handle with dry instruments or gloves and avoid contact with tissue surfaces until placement; in case of re-bleeding, apply additional Datsing BioPaper®; reported safe in MR environment with no MR image artifact effects.

Technical specifications

• Commercial name: Datsing BioPaper®.
• Composition: polysaccharide-based biodegradable membrane (paper-like).
• Form: thin membrane that forms a transparent gel layer upon contact, enabling adhesion and sealing.
• Degradation: manufacturer statement of biodegradation into CO2 and H2O within 28 days; experimental animal data show complete degradation within 12 weeks.
• Maximum recommended area per patient: 360 cm2 (≈ nine pieces of 5 cm × 8 cm).
• Sterility and use: supplied sterile; single-use only; must not be re-sterilized.
• Intended operator: trained physicians.
• MR compatibility: reported safe in MR environment with no imaging artifacts.